A PHASE-II STUDY IN ADVANCED GASTROESOPHAGEAL CANCER USING EPIRUBICINAND CISPLATIN IN COMBINATION WITH CONTINUOUS-INFUSION 5-FLUOROURACIL (ECF)

Purpose: A phase II study was performed in patients with unresectable or metastatic gastric cancer evaluating the efficacy of a new chemothe rapy schedule combining epirubicin and cisplatin with a continuous amb ulatory infusion of 5-fluorouracil (ECF). Patients and methods: One hu ndred thirty-nine consecutive, previously untreated patients were give n ECF. Of these, 128 had measurable disease. Epirubicin (50 mg/m2 i.v. ) and cisplatin (60 mg/m2 i.v.) were administered every three weeks fo r 8 cycles during a 21 week continuous i.v. infusion of 5-fluorouracil (200 mg/m2/day). In total 773 cycles of chemotherapy were given. Resu lts: Objective tumour responses was seen in 91 (71%) of the 128 patien ts with measurable disease, of which 15 (12%) had a complete response. Twenty patients with locally advanced disease responding to ECF had a ttempted resection of the primary - 11 (55%) were completely removed, 4 of these had no residual tumour in the resected specimen. The overal l median survival was 8.2 months with 1 and 2 year survivals of 30% an d 10% respectively. Grade 3 or 4 emesis occurred in 13%, stomatitis in 7%, diarrhoea in 4%, infection in 6%, leucopenia in 21% and thrombocy topenia in 8% of patients. Myelosuppression delayed treatment in 39 (5 %) of the 773 cycles. Six of the 139 patients (4.3%) had treatment rel ated deaths. There was no measurable reduction in quality of life duri ng chemotherapy, while 67% of the 66 patients with dysphagia had compl ete resolution of this symptom. Conclusions: The ECF regimen displays high anti-tumour activity with moderate toxicity in patients with gast ric cancer and in some cases enabled resection of previously inoperabl e tumours.